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Quality Engineer

Corbion develops sustainable solutions to improve the quality of life for people today and for future generations.

 

The Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry. Our products are used, among other things, in the production of surgical aids and slow-release medicines (injection pills). The products are developed and produced (often to customer specifications) in our factories in The Netherlands and the United States, this requires very intensive contact with the customer.

 

The application area and the specific market require a very high level of Quality and service. The Corbion Biomaterials Quality Assurance department ensures that raw materials, production processes, packaging, storage, transport and service continuously meet and exceed these high standards. This makes sure that our customers receive the consistent high Quality product from Corbion that they have become accustomed to.

 

The Quality Engineer is responsible for ensuring procedures, systems, and processes effectively meet the Quality requirements and business needs for the site in Tucker, GA USA. The ideal candidate must have proven skills in developing and maintaining Quality systems. In this role, you will be responsible for creating Quality Management System (QMS) procedures that are in compliance with GMPs and applicable standards and regulations including ICH Q7 and ISO 9001:2015. You will also serve as a core member of the Polymers team to ensure that products are developed and produced in compliance with QMS procedures.

 

Responsibilities:

 

  • Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO requirements.
  • Quality Reviewer/Approver for Validation and Production Documentation.
  • Develop Quality Plans for new and existing products.
  • Support Commissioning and validation activities for new equipment.
  • Support creation and execution of validation protocols.
  • Provide direct Quality support to Production, including line clearance, CAPA/Deviations/Change Control, etc.
  • Assist in the development of appropriate statistical measurements.
  • Create/review processes/procedures including for Quality, Risk Management, Monitoring, Production, etc.
  • Participate in and provide guidance to risk management activities such as FMEA.
  • Support the establishment of proper controls and sampling for manufacturing activities.
  • Perform data trending.
  • Support Quality Assurance with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, and Complaint handling.
  • Support internal and external customers’ Quality requests with timely follow up and participation in new business development projects.

 

 

Minimum Qualifications:

 

As a successful candidate you are a seasoned professional with experience in pharma, medical device, or related FDA regulated industry. You have working knowledge of GMP regulations, primarily ICH Q7; ISO 13485; ISO 14971; ISO 9001:2015 and/or other applicable GMP regulations.

 

In addition we expect the following qualifications:
 

  • Bachelor’s or Master's degree in Life Sciences, Engineering, or other relevant discipline.
  • Minimum 5 years of Quality Assurance experience in pharmaceutical, medical device or other related industries.
  • Strong written and verbal communication skills.
  • Some exposure to regulatory agency inspections (e.g. FDA, notified bodies, etc.).
  • Proven ability to work cross-functionally to achieve business outcomes.
  • Attention to detail, commitment to Quality, accuracy, efficiency, and consistency.
  • Experience executing validation protocols.
  • Experience leading and/or executing risk assessment activities, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
  • Skills in statistical methods, statistical process control, sampling plans, and design of experiments.
  • Proficiency using the Microsoft Office Suite.
  • Self-motivated, and possess strong organizational skills, and outstanding written and verbal communication skills.
  • A positive, team-player attitude is a must.
  • Must be able to multi-task, meet tight deadlines, and prioritize changing demands in a fast-paced environment.
  • Requires high accuracy, thoroughness, and attention to detail in reviewing and completing quality records.
  • Preferable ASQ certification – Certified Quality Engineer (CQE).

 

Our offer

 

We offer competitive remuneration and benefits. What makes Corbion special is the way we consciously create that connection between the product of our work and our individual lives and use it to shape our choices and our priorities as a company. We have a great company made up of talented, dedicated people – people who share a purpose and a vision. When we all understand how we intend to get there in the same way, there’s no telling how far we can go. We offer you the chance to join a company with a:

 

  • Culture to empower people and where your initiatives and ideas make a real difference
  • International focus with truly diverse teams
  • Unique possibility to be trained by our internal expertise in the world of biobased products
  • We invest in relevant training courses related to your particular discipline, that will give you the opportunity to grow into an industry expert
  • Lastly, we offer a friendly, informal culture in a demanding professional environment

 

In addition, we actively embrace diversity in how we work together and contribute toward our shared objectives and values. By joining Corbion, you will become an employee in a company where you can feel pride in your achievements and develop your career with global prospects.

 

 

About Corbion

Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2019, Corbion generated annual sales of   € 976.4 million and had a workforce of 2,138 FTEs. Corbion is listed on Euronext Amsterdam. For more information: www.corbion.com

 

Corbion is an equal opportunity employer and committed to a diverse workplace.  All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors.

 

Corbion provides reasonable accommodation to applicants with disabilities.  If you need a reasonable accommodation for any part of the application and hiring process, please notify the Corbion Human Resources department.  The decision on granting reasonable accommodation will be on a case-by-case basis.

 

EOE/M/F/Vet/Disabled

 

Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.

Company
Corbion
Posted
09/24/2020
Salary Range
$56,000.00 - 87,000.00
per Year
Salary range estimated by
Location
Tucker, GA 30084, US